An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants

August 28, 2018 updated by: Bristol-Myers Squibb

A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects

The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Utah
      • Salt Lake City, Utah, United States, 84107
        • PRA Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
  • Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening

Exclusion Criteria:

  • Women of childbearing potential
  • Any significant acute or chronic medical illness
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy

Other protocol defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rifampin + BMS-986224
Oral administration
Specified dose on specified days
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax) of BMS-986224
Time Frame: 5 days
5 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
Time Frame: 5 days
5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Biomarker plasma concentrations of BMS-986224
Time Frame: 5 days
5 days
Time of maximum observed plasma concentration (Tmax) of BMS-986224
Time Frame: 5 days
5 days
Terminal elimination half-life (T-HALF) of BMS-986224
Time Frame: 5 days
5 days
Metabolite of BMS-986224 Cmax
Time Frame: 5 days
5 days
Metabolite of BMS-986224 AUC(0-T)
Time Frame: 5 days
5 days
Metabolite of BMS-986224 AUC(INF)
Time Frame: 5 days
5 days
Incidence of nonserious adverse events (AE)
Time Frame: 17 days
17 days
Incidence of serious adverse events (SAE)
Time Frame: 30 days
30 days
Incidence of AEs leading to discontinuation
Time Frame: 17 days
17 days
Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests
Time Frame: 18 days
18 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

July 27, 2018

Study Completion (Actual)

July 27, 2018

Study Registration Dates

First Submitted

June 11, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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